According to the company, the indications for these deviceswhich may vary by regioninclude the following: Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Malformations are an abnormal tangle of blood vessels that cause arteries to shunt directly into veins, the blood flow never slows down enough to provide oxygen and nutrients. Corporate Communication Dept., Terumo Corporation. BOBBY | MicroVention Note: Choose 8F (2.92mm / 0.115in) ID introducer sheath or larger. It has been designed to streamline balloon preparation, while improving navigability and ensuring compatibility with the SOFIA Plus 6Fr Aspiration Catheter. The prestigious award is based entirely on what current employees say about their experience working at MicroVention. The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. Online ahead of print. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Copyright 2023 Terumo Corporation, All Rights Reserved. Looking for more information about this product? The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. Founded in 1997 by a handful of Associates in Southern California, MicroVention is now a worldwide community with over 3,000 Associates and distributors worldwide, with offices across the United States, Europe, Asia, and CostaRica. The BOBBY device streamlines the balloon preparation and improves navigability as well as compatibility with the SOFIA Plus 6Fr Aspiration Catheter. A 360-Degree Approach to NeuroendovascularTherapy, MicroVention Earns 2022 Great Place to WorkCertification. Proximal variable pitch braid reinforcement provides support and torque control, Hand shapeable distal tip allows for quick, easy tip shaping saving time and helping navigate challenging anatomy, The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. Exceptionally soft distal segment allows forexcellent navigability and trackability into distal anatomy, enabling the SOFIA Catheter to provide support close to the treatment site, Hybrid Braid and Coil Design provides 1:1 push/pull control for enhanced trackability. Guidewires. In addition, we provide multiple-access product configurations that include a variety of length, flexibility, shape, inner and outer diameter, design, and material. Delivers atraumatic flow arrest without sacrificing aspiration power or time. With stainless steel double braid and five transition zones. The new balloon guide catheter has been designed for use in enabling insertion and intravascular catheter guidance into a selected blood vessel in the peripheral and neurovascular systems. Aliso Viejo, CA April 20, 2022 MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. Visit our contact page for information on how to place an order by phone, fax or email. from 8 AM - 9 PM ET. Our cutting-edge products lead the way in neuroendovascular therapies. Find clinical trials, studies and registries involving this product. We took a novel approach by designing a ready-to-use liquid embolic device formalformations. We were pleased with the excellent performance of the Bobby balloon guide catheter with the Sofia Plus 6-F aspiration catheter, Headway microcatheter, Traxcess EX guidewire, and the 6 X 40 stent retriever revascularization device.. Now its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice, such as transfusion systems, diabetes care, and peritoneal dialysis treatments. The first enrolled patient for the STRAIT study was treated with the Bobby device by Christian Maegerlein, MD. ", Carsten Schroeder, President and CEO of MicroVention, Inc. noted that, "The STRAIT trial is intended to provide clinical evidence that MicroVention's new balloon guide catheter can effectively contribute to improved clinical outcomes.". Our access product portfolio enables physicians to gain access to the brain through a minimally invasive treatment called endovascular therapy. Additionally, the Sofia catheter is intended for use in the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures. Last January, MicroVentions WEB 17 System, a new addition to the WEB Aneurysm Embolization System, received FDA approval. Endovascular procedures offer many advantages, including a shorter recovery period, less discomfort, a small incision, and fewer risks for patients that have other medical conditions.*. Our focus is to provide ideal, integrated comprehensive solutions, easy-to-use products, and proven best practices to fulfill our customers needs from start to finish. MicroVention advised that the Bobby balloon guide catheter is currently approved in Europe and in North America. The Bobby balloon guide catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. MicroVention Announces First Patient Enrolled in the STRAIT Study with Evaluation of the safety and performance of the BOBBY Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Learn more about MicroVention's groundbreaking disease treatments. Recruiting. Come work alongside us in a rewarding and relaxed environment. BOBBY Balloon Guide Catheter for Endovascular Treatment of | Clincosm FlowGate Balloon Guide Catheter Brochure, See package insert for complete indications, complications, warnings, and instructions for use. 510(k) Premarket Notification - Food and Drug Administration STRAIT is evaluating the safety and performance of the companys Bobby balloon guide catheter for endovascular treatment of acute ischemic stroke. MicroVention recruits first patient in STRAIT study of BOBBY catheter A microcatheter is a small diameter catheter that can be tracked over a guidewire in order to reach the target lesion. It provides a balance of trackability and support with a large lumen and is indicated for use as a conduit for retrieval devices. The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Dr. med. Designed with the latest microbraid technology, the WEB 17 System is intended for the treatment of intracranial wide-neck bifurcation aneurysms. Custom coils in one week: Two years on from the launch of QwikCoil, whats next for Custom Wire Technologies? The leading site for news and procurement in the medical device industry, Nanotech knowledge grows to progress tuberculosis treatment, Sterilisation innovation to prioritise patient safety, Transcatheter accessories becoming more specialised, MedShift receives $45m loan from Turning Rock, TeraRecon launches new AI-powered Neuro Suite platform, Nuvo Group signs LOI to combine with SPAC to go public, Twinn.health introduces AI-based imaging platform for age-related diseases, FDA grants Ultromics EchoGo Amyloidosis platform breakthrough device status, Medtronic reports increase in Q3 2023 global revenue, BD reports 2.8% decline in Q1 2023 revenues, The six crucial advantages of Software as a Service for eIFU. 2022 May 30;15910199221104920. doi: 10.1177/15910199221104920. This year, 80% of employees said its a great place to work 21 points higher than the average U.S.company. A brain aneurysm is a weak, bulging spot on the wall of an artery. About the SOFIA Aspiration CatheterThe SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. The Bobby balloon guide catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. About Us | MicroVention Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. A stroke is a permanent injury to the brain caused by a blockage of blood flow that deprives brain tissue of oxygen and nutrients. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. An endovascular procedure requires a small incision made near the hip in order to access the blood vessels. We were pleased with the excellent performance of the BOBBYBGCwith the SOFIA Plus 6Fr Aspiration Catheter, Headway Microcatheter, Traxcess EX Guidewire and the 6x40 stent retriever revascularization device. The SOFIACatheter is designed for distal navigation and supports precise delivery of a variety of neurovascular therapies. MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. MicroVention, Inc., a global neurovascular company and a wholly owned subsidiary of Terumo Corporation, celebrates its 25-year anniversary on September 29, 2022. The SOFIA 5F catheter is compatible with guide or balloon guide catheters with an ID of 0.070" or larger. During these, and other angiographic procedures, the balloon provides temporary vascular occlusion. The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. Date Received: 12/26/2019: Decision Date: 07/21/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel We strive to provide a wide range of innovative, high-quality access products designed to improve patient outcomes. Read more Terumo (TSE: 4543) is a global leader in medical technology and has been committed to Contributing to Society through Healthcare for 100 years. Headquartered in California, MicroVention products are sold in more than 75 nations through a direct sales organization alongside strategic distribution partnership. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Designed with ScepterMinis self-sealing purge valve to simplify and decrease balloon prep time. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Ist Patient Enrolled in Balloon-Guide Catheter Study Learn more about MicroVention's groundbreaking disease treatments. Find clinical trials, studies and registries involving this product. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. A balloon catheter is a type of soft catheter with an inflatable balloon at its tip. Access Product Solutions | MicroVention Media Contact: Cathy Demyanovich Sr. Director, Corporate Communications MicroVention, Inc. +1-714-247-8000. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Indications may vary by region. The Headway microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. Once the blood vessels are accessed, a catheter is typically inserted through this small incision and guided to the location of the brain where treatment is necessary. A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU). Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The new balloon guide catheter has been designed for use in enabling insertion and intravascular catheter guidance into a selected blood vessel in the peripheral and neurovascular systems. The BOBBY Balloon Guide Catheter is currently approved in Europe and in North America. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. An intermediate catheter is designed to help provide stability by reducing the tendency of the microcatheter to move during delivery/implantation of medical devices. The SOFIACatheter is indicated for general intravascular use, including the neuro and peripheral vasculature. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. Made inHAUSHAUS is a creative design agency based in Los Angeles, California, Ischemic Stroke and Carotid Artery Disease. The WEB System is the first and only PMA approved device in the new category of intrasaccular flow disruptors for aneurysm embolization. Our unique portfolio for ruptured and unruptured aneurysms is backed by numerous clinical studies and independent research for great performance andversatility. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Created with Sketch. Latest "Balloon Occlusion Device Market" Highlights 2023 - MarketWatch Tobias Boeckh-Behrens, Department of Diagnostic and Interventional Neuro Radiology (Klinikum rechts der Isar der Technischen Universitt Mnchen). Terumo will further strive to be of value to patients, medical professionals, and society at large.www.terumo.com, Media Contact:Cathy DemyanovichSr. The guidewire can be steered to facilitate the selective. TIS Division (Terumo Interventional Systems), Cardiovascular Division (Terumo Cardiovascular)/ HeartSheet Division, Terumo Blood and Cell Technologies Company (Terumo Blood and Cell Technologies), Creating a Diverse and Inclusive Workplace. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. It has been designed to assess the BOBBY balloon guide catheters safety and performance for endovascular treatment of acute ischemic stroke. Terumos acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. This year, 80% of employees said its a great place to work 21 points higher than the average U.S. company. The first patient for the STRAIT study was enrolled at the site of the Principal Investigator PD. The deflated balloon catheter is positioned, inflated to perform the necessary procedure, and deflated again in order to be removed. Aliso Viejo, California andAlajuela, Costa Rica, April 11, 2023 MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today hosted the Republic of Costa Ricas President Rodrigo Chaves Robles and other government officials and dignitaries at its Costa Rica facility inAlajuela. Clinical Education. Aliso Viejo, CA - April 20, 2022 - MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced the successful completion of its first enrollment in a multi-center, prospective EU observational study called STRAIT, to evaluate the Safety and Performance of the BOBBY Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke. MicroVention Announces First Patient Enrolled in the STRAIT - BioSpace Find clinical trials, studies and registries involving this product. Integrated guiding catheter system offering support and a large inner diameter lumen, featuring a unique inner catheter option for rapid atraumatic access, Thin PTFE layer and flat wire braid creates increased lumen diameter, Soft inner catheter options with Hydrophilic Coating. MM1331 NA 02/23 Last Updated . Authors Karan Topiwala 1 , Coridon Quinn 1 , Tapan Mehta 1 , Kamran Masood 1 , Andrew Grande 1 , Ramachandra Tummala 1 , Bharathi Jagadeesan 1 Coil reinforcement provides lumen integrity, flexibility and excellent shape retention. Wallaby Medical Acquires German Neurovascular Company Phenox GmbH, left-arrow The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Aneurysm Therapy Solutions, Ischemic Stroke & Carotid Artery Disease Solutions, Neurovascular Malformation Solutions, and Access Products. Access Product Solutions. right-arrow News Detail | Microvention placement of diagnostic or therapeutic catheters. The Sofia catheter can be used to facilitate introduction of diagnostic or therapeutic agents. Ischemic Stroke and Carotid Artery Disease. Dr. Maegerlein commented in MicroVentions press release, A severe stroke case with a left carotid occlusion was successfully treated with the use of the Bobby, resulting in a first pass TICI [thrombolysis in cerebral infarction] 3, 20 minutes after groin puncture. We were pleased with the excellent performance of the BOBBY BGC with the SOFIA Plus 6Fr Aspiration Catheter, Headway Microcatheter, Traxcess EX Guidewire and the 6x40 stent retriever revascularization device., Carsten Schroeder, President and CEO of MicroVention, Inc. noted that, The STRAIT trial is intended to provide clinical evidence that MicroVentions new balloon guide catheter can effectively contribute to improved clinical outcomes.. The device is not intended for use in coronary arteries.
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